[No public or meaningful name is available]

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is taken from a secondary source

Data source

Reference

Reference Type:

other: Secondary source

Title:

SIDS Initial Assessment Report For SIAM 17

Author:

OECD-SIAM

Year:

2003

Bibliographic source:

OECD SIDS, SIAM, 2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1983

Principles of method if other than guideline:

Acute inhalation of the given test sample was studies in Rats to determine LC50 value

GLP compliance:

not specified

Test type:

other: Standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropyltriethoxysilane

EC Number:

213-048-4

EC Name:

3-aminopropyltriethoxysilane

Cas Number:

919-30-2

Molecular formula:

C9H23NO3Si

IUPAC Name:

3-AMINOPROPYLTRIETHOXYSILANE

Test material form:

liquid

Details on test material:

Purity : = 98 - 100 % v/v

Specific details on test material used for the study:

Not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) No data Avaiable
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data Avaiable
- Rationale for use of males (if applicable) No data avaiable
- Age at study initiation: Approximately 9 weeks old
- Weight at study initiation: No data avaiable
- Fasting period before study: No data avaiable
- Housing:No data avaiable
- Historical data:No data avaiable
- Diet (e.g. ad libitum): No data avaiable
- Water (e.g. ad libitum): Distill water
- Acclimation period: No data avaiable
- Microbiological status when known No data avaiable
- Method of randomisation in assigning animals to test and control groups No data avaiable

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data avaiable
- Humidity (%): No data avaiable
- Air changes (per hr): No data avaiable
- Photoperiod (hrs dark / hrs light): No data avaiable

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

not specified

Mass median aerodynamic diameter (MMAD):

1.6 µm

Geometric standard deviation (GSD):

2.19

Remark on MMAD/GSD:

Saturated vapors

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Solo-Sphere® nebulizer
- Exposure chamber volume: 120-liter exposure chamber
- Method of holding animals in test chamber: No data avaiable
- Source and rate of air (airflow): No data avaiable
- Method of conditioning air:No data avaiable
- System of generating particulates/aerosols: No data avaiable
- Method of particle size determination: No data avaiable
- Treatment of exhaust air: No data avaiable
- Temperature, humidity, pressure in air chamber: No data avaiable

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: gas chromatographic analysis.
- Samples taken from breathing zone: No data avaiable
- Time needed for equilibrium of exposure concentration before animal exposure No data avaiable

VEHICLE
- Composition of vehicle (if applicable): No data avaiable
- Concentration of test material in vehicle (if applicable): No data avaiable
- Justification of choice of vehicle: No data avaiable
- Lot/batch no. (if required): No data avaiable
- Purity: No data avaiable

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: particle size distribution for the test material was determined with a cascade impactor
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD : 1.6 micrometers with a geometric standard deviation of 2.19

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration:

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Remarks on duration:

Not specified

Concentrations:

Not specified

No. of animals per sex per dose:

5animals /sex/ dose

Control animals:

not specified

Details on study design:

Not Specified

Statistics:

standard deviation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

7.35 mg/L air

Based on:

test mat.

95% CL:

>= 6.65 - <= 9.52

Exp. duration:

4 h

Remarks on result:

other: SD 0.92

Mortality:

LC50 was note at 7.35mg/L

Clinical signs:

other: During exposure, a dense fog was present within the animal chamber, preventing observation of the test animals. After exposure, slow righting reflex, labored breathing, hypoactivity, ataxia and discharge from the mouth, nose, and eyes were apparent.

Body weight:

All animal gain weight during study

Gross pathology:

Necropsy findings, included doses affected, severity and number of animals affected: No remarkable gross pathologic findings were seen.

Any other information on results incl. tables

Sex	Analytical Conc. (mg/l)	Mortality (No./total)	Mean body weight change (g) 0-7 days	Mean body weight change (g) 0-14 days	Overt toxicity	Number with remarkable gross pathology
males	7.35 (6.65-9.52)	0/5	12 (8-17)	28 (24-30)	On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth, or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3.	0/5
females	7.35 (6.65-9.52)	0/5	2 (2-8)	9 (5-12)	On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth,or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3.	0/5

Table 1: Concentrations, mortality or evident toxicity

LC50 (males and females): > 7.35 mg/l (mean concentration)

Mean ethanol concentration was 3253 (standard deviation of 1621) ppm (equivalent to around 6.1 mg/l)

Applicant's summary and conclusion

Interpretation of results:

other: Not Classified

Conclusions:

In a study, conducted in accordance with generally accepted scientific standards and probably according to GLP, male and female rats exposed to a 60% aqueous solution of the test substance achieved an LC50 of over 7.35 mg/l after four hours.

Executive summary:

The Read across sample was administered to all animals in five species/sex/doses. The body weight of all the surviving animals was found to be increased. On completion of exposure: slow righting reflex, labored breathing, hypoactivity, ataxia. Red encrustation around nose, mouth, or eyes that remained for 1 or 2 days. No abnormalities were detected on day 3. Necropsy findings, including doses affected, severity, and a number of animals affected: No remarkable gross pathologic findings were seen. Five rats were exposed for four hours to 7.35 mg/l of a 60% of test solution. The animals were observed during the subsequent 14-day post-exposure period. After exposure, slow righting reflex labored breathing, hypoactivity, ataxia, and discharge from the mouth, nose, and eyes were apparent. At 3 days, the animals were fully recovered Hence the test chemical cannot be classified according to CLP Criteria for classification.